Financial Toxicity and Quality of Life in Patients With TGCT

Recruiting

• Conditions: Testicular Neoplasm
• Interventions: Other: Comprehensive Score for financial toxicity (COST); Other: EORTC QLQ C-30; Other: EORTC QLQ-TC26.

• Registration Number: NCT04531709
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-28
• Study Start: 2023-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-04-30
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Age > 18 years of age
• Patients with histologically or clinically confirmed germ cell tumor.
• Completed treatment for germ cell tumor with multicycle (> 2 cycles) / multiagent chemotherapy.
• Within years 1-5 of surveillance since Day 1 of last cycle of chemotherapy
• Signed informed consent

Exclusion Criteria

• Long-term survivors

  • Patients undergoing active chemotherapy
  • Patients who did not complete 1st line chemotherapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recently diagnosed TGCT	EORTC QLQ-TC26.	-
Recently diagnosed TGCT	Comprehensive Score for financial toxicity (COST)	-
Recently diagnosed TGCT	EORTC QLQ C-30	-
Long-term survivors of TGCT	Comprehensive Score for financial toxicity (COST)	-
Long-term survivors of TGCT	EORTC QLQ C-30	-
Long-term survivors of TGCT	EORTC QLQ-TC26.	-

Primary Outcome Measures

Name	Time	Method
Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high.	5 years

Secondary Outcome Measures

Name	Time	Method
Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT.	5 years

Trial Locations

Locations (1)

Mays Cancer Center; 🇺🇸 San Antonio, Texas, United States